IL291793B2

IL291793B2 - Tiltingly oscillating ultrasound treatment device

Info

Publication number: IL291793B2
Application number: IL291793A
Authority: IL
Inventors: Ilan Feferberg
Original assignee: Ilan Feferberg
Priority date: 2022-03-29
Filing date: 2022-03-29
Publication date: 2023-12-01
Also published as: WO2023187774A1; IL291793B1; IL291793A

Description

IL291793/ TILTINGLY OSCILLATING ULTRASOUND TREATMENT DEVICE FIELD OF THE INVENTION The present invention relates, in general, to methods and devices for ultrasound energy treatment, and, in particular, to aesthetic and therapeutic treatment using ultrasound devices.

BACKGROUND OF THE INVENTION Ultrasound therapy is an electrotherapy which has been used in physiotherapy practices for almost a century. Ultrasound therapy is mainly used for its non-thermal effect, as high frequency sound waves initiate vibrations and activity of cellular material, which may improve the healing rate of certain soft tissues. In particular, ultrasound energy may increase blood flow in the applied area, so as to accelerate the resolution time of an inflammatory process, and to stimulate the production of collagen (the main protein in tendons and ligaments) during tissue healing. Common injuries treated with ultrasound include: bursitis, tendonitis, muscle strains and tears, osteoarthritis, and ligament and tendon injuries. In recent years, the use of physiotherapy tools and techniques for aesthetic body treatments, also referred to as "physio- aesthetics" is becoming more prevalent, and there is a proliferation of physiotherapy centers and practitioners offering aesthetic treatments alongside customary therapeutic treatments.

The accepted technique of applying ultrasound treatment involves an operator positioning an ultrasound transducer on the skin in the region of the tissue requiring treatment, and performing slow massaging movements in a IL291793/ circular or stroking movement pattern (e.g., back-and-forth and/or side-to-side).

The circular or stroking movement pattern serves a dual purpose, firstly by creating a massaging effect which combines with the ultrasound radiation to enhance the therapeutic effect on the treated tissue, and secondly by distributing the treatment over an expansive region which encompasses the tissue to be treated.

The pace at which the transducer is advanced along the skin may derive from conflicting factors. On the one hand, the need for effective energy absorption in the internal tissue requires retaining the transducer in a fixed position on the body. On the other hand, to prevent damaging of the skin and subcutaneous tissue requires shortening the radiation time at any one position.

This conflict is exacerbated by the fact that the radiation energy is highest at the tip of the transducer and dissipates rapidly as the radiation propagates through the tissue layers. This intensifies the need for prolonging the energizing of the internal tissue at a sufficiently high energy level, in order to procure a desired therapeutic or aesthetic effect, while also, however, elevating the risk of harm to outer skin and subcutaneous tissues as the energy level is raised and the energizing time is extended at any one position.

A comprehensive review conducted by Robertson and Baker (Physical Therapy, Volume 81, Issue 7, 1 July 2001, Pages 1339–1350), questioned the effectivity of the accepted and prevalent form of treatment of applying ultrasound energy to treat various physiotherapeutic issues. After analyzing 35 studies they concluded that "there was little evidence that active therapeutic ultrasound is more effective than placebo ultrasound for treating IL291793/ people with pain or a range of musculoskeletal injuries or for promoting soft tissue healing".

Korean Registered Patent no. 102094905, to IUCF Sunmoon Univ (KR), entitled "Hand-piece of Ultrasonic Therapy System for Treatment, and Ultrasonic Therapy System for Treatment Having the Same" discloses a hand- piece body with an ultrasonic ceramic unit positioned at its front end, configured to be in contact with the skin of a patient and to irradiate ultrasonic energy to the skin of the patient. An ultrasonic ceramic rotation motor which is positioned in the hand-piece body rotates the ultrasonic ceramic unit flatly against the skin of the patient, and a ceramic supporting spring member elastically supports the ultrasonic ceramic unit to improve massaging ability along a curved surface. By automatically rotating the ultrasonic ceramic unit in contact with the skin, the invention is intended to facilitate a stable therapy for prolonged time periods, improve ultrasonic therapy efficiency, and prevent the operator developing wrist pains and infections.

U.S. Patent Application No. 2012/0310232 to Erez, entitled: "System and method for treating a tissue using multiple energy types", is directed to skin treatment using a combination of non-focused ultrasound and radio frequency (RF) energies. At least two flat transducers is configured to produce sound waves at surface and inner layer of the skin. A plurality of RF electrodes is configured to emit a plurality of RF signals. A control unit is configured to control the transducers such that an interference of the sound waves sustains a predefined level of energy at a specific tissue below the surface of the skin.

Japan Patent Application No. 2009291600A to TEIJIN PHARMA LTD, entitled: "Oscillator fixture having oscillator angle-varying mechanism", IL291793/ discloses an oscillator fixture for an ultrasound transducer. The oscillator fixture included one or two or more shafts and is divided into two or more structures, which are connected to each other by an angle variable rotating mechanism.

U.S. Patent Application No. 2011/0112445 to Naldoni, entitled: "Handpiece for ultrasound treatments of human tissue", discloses a handpiece to carry out ultrasound treatments of human tissue to remove localised adiposity, cellulite, etc. The handpiece comprises a box-shaped body presenting a basin-like concave element, the contour of which (CNT), in use, is rested on the skin to be treated. The handpiece comprises two ultrasound transducers located on the walls of the concave element, the ultrasound transducers being inclined with respect to each other at an angle adjustable by electromechanical means. Between the two ultrasound transducers is a suction mouth connected to a vacuum pump. The suction mouth is suited to lift a portion of skin, in such a way that two adjoining portions of skin, covered with massage oil or gel, are brought into contact with the ultrasound transducers.

Korean Patent Application Publication No. 20170048289A, entitled: "Ultrasound cartridge for high intensity focused ultrasound device", discloses an ultrasound cartridge for high intensity focused ultrasound device used in connection with an operation handpiece of an ultrasonic apparatus for skin beauty treatment. The ultrasound cartridge is detachably attached to the operation handpiece. A cartridge body is filled with a medium for transmitting ultrasound to one side and having a transmitting member for transmitting ultrasonic waves. An ultrasound diagnostic unit is provided in the cartridge body for generating a thermal focal point of the high intensity focused ultrasound (HIFU) non-invasively at a predetermined depth from the surface of the skin IL291793/ through the permeable member during operation. The ultrasound therapy unit includes a first transducer and a second transducer for converting electrical energy into ultrasonic energy, where the transducers may be sequentially disposed along a longitudinal direction of the handpiece.

U.S. Patent Application No. 2018/0353778 to Jeong, entitled: "Therapeutic ultrasonic wave generating device", discloses a device that includes a rotating motor, an ultrasonic wave generating unit provided with a transducer generating ultrasonic waves, and a focus rotation movement unit moving the focus of the ultrasonic waves generated by the ultrasonic wave generating unit in a circle on the same plane by receiving a transmission of rotational force of the rotating motor. The device enables the focus of ultrasonic waves to be moved in the circle having a constant radius at a uniform depth under the skin, and energy to be applied uniformly and evenly within the movement radius, for enhancement of therapeutic performance.

IL291793/ SUMMARY OF THE INVENTION In accordance with one aspect of the present invention, there is thus provided a system for therapeutic and/or aesthetic ultrasound treatment. The system includes an ultrasound device and a measurement assembly. The ultrasound device includes at least one tilting ultrasound transducer, including a body interface implement, the tilting ultrasound transducer configured to be deployed and transmit ultrasound energy onto a skin tissue overlying a treatment region of an internal tissue of a treated body part, such that the body interface implement interfaces with a surface of the skin tissue. The ultrasound device further includes a motor-driven oscillator, coupled with the tilting ultrasound transducer, and configured to oscillate about an oscillation-axis relative to a surface of the skin tissue such that at least one of: a position of the body interface implement; and a tilt direction of the body interface implement, oscillates about the oscillation-axis. The measurement assembly is configured for measuring body shape parameters of the treated body part with the ultrasound device. The measurement assembly includes: a green screen; a plurality of scale-markers; at least one imaging device; and a processor. The scale markers are positioned at a predetermined respective distance from each other to form a one-dimensional or two-dimensional plane parallel to the green screen, where the one-dimensional or two-dimensional plane is shared by the treated body part. The imaging device is operational for capturing images of the treated body part and the scale-markers on a background of the green screen.

The processor is configured to receive the images from the imaging device and to process the images to measure body shape parameters of the treated body part. A propagation direction of the ultrasound energy may be tilted respective IL291793/ of the surface of the skin tissue at a non-perpendicular angle. The oscillator may be configured to oscillate the propagation direction of the ultrasound energy by dynamically changing a transmittal direction of the ultrasound waves relative to the body interface implement. A plurality of ultrasound transducers may be positioned on the skin tissue, and the oscillator may be configured to oscillate the propagation direction of the ultrasound energy by activating and deactivating each of the ultrasound transducers respectively according to a sequence pattern. The body interface implement may be configured to be tilted with respect to the surface of the skin tissue, forming a non-straight tilting transducer angle between an axis parallel to the body interface implement and an axis parallel to the skin surface, and the oscillator may be configured to oscillate so ad to dynamically change the tilting transducer angle while massaging the skin tissue. The oscillator may be moveable along a trajectory.

The ultrasound device may further include a distal engagement ring, encompassing the tilting ultrasound transducer and configured to be selectively extended in a distal direction to engage the skin tissue, so as to stabilize the ultrasound device when the tilting ultrasound transducer is activated. The ultrasound energy may be at a frequency in the range of 0.5-4.5 MHz. The ultrasound energy may be at an intensity in the range of 0.1-3.5 W/cm. The body interface implement may be configured to be tilted with respect to the surface of the skin tissue, forming a tilting transducer angle in the range of 0.5°- ° between an axis parallel to the body interface implement and an axis parallel to the surface of the skin tissue. The tilting transducer angle may be 3.5°. A propagation direction of the ultrasound energy within the internal tissue may form a divergent conic-like pattern or a convergent conic-like pattern. The IL291793/ ultrasound device may further include a plurality of electrodes configured to apply interferential electrical stimulation to the skin tissue during the operation of the transducer. The ultrasound device may further include at least one suction unit configured to apply vacuum suction to the skin tissue during the operation of the tilting ultrasound transducer. The ultrasound device may include at least one stabilizing arm coupled with a main body of the device for stably positioning the ultrasound device at the skin tissue allowing automatic maneuvering of the device to roam over the skin tissue. The ultrasound device may include at least one non-tilting ultrasound transducer, configured to be deployed onto the skin tissue and transmitting ultrasound energy on to the skin tissue. The oscillation of a plurality of the tilting ultrasound transducers may be coordinated to create an interference pattern in the internal tissue. A plurality of the ultrasound transducers may form an integrated transducer unit configured to oscillate at the skin tissue, such that each transducer in the unit moves correspondingly with the oscillation of the unit.

IL291793/ BRIEF DESCRIPTION OF THE DRAWINGS The present invention will be understood and appreciated more fully from the following detailed description taken in conjunction with the drawings in which: Figure 1A is an illustration of an ultrasound device, constructed and operative according to an embodiment of the present invention; Figure 1B is a cross-sectional illustration of the ultrasound device of Figure 1A; Figure 1C is an enlarged cross-sectional illustration of a distal portion of the ultrasound device of Figure 1B; Figure 1D is an illustration of the ultrasound device of Figure 1A, shown from its distal end; Figure 1E is an illustration of the ultrasound device of Figure 1A and an energized area of a body part which receives ultrasound energy transmitted by the device; Figure 1F is an illustration of an ultrasound device with an ultrasound transducer having a ring-shaped skin contact section, constructed and operative according to an embodiment of the present invention; Figure 1G is a bottom view of the ultrasound device of Figure 1F; Figure 2 is an illustration of an ultrasound device including stabilizing arms, constructed and operative according to an embodiment of the present invention; Figure 3A is an illustration of an ultrasound device including a plurality of tilting ultrasound transducers, constructed and operative in accordance with another embodiment of the present invention; IL291793/ Figure 3B is an angled overhead view illustration of the transducers of the ultrasound device of Figure 3A, tiltingly rotating to shift the location of the constructive interference within the internal tissue, constructed and operative in accordance with another embodiment of the present invention; Figure 4 is an overhead view illustration of a trajectory along which an ultrasound device is maneuvered over a skin tissue, operative in accordance with an embodiment of the present invention; Figure 5 is an illustration of a measurement assembly, constructed and operative in accordance with an embodiment of the present invention; and Figure 6 is a block diagram of a method for treatment of an internal tissue of a patient, operative in accordance with an embodiment of the present invention.

Figure 7 is a block diagram of sub procedures of a procedure of the method for treatment of an internal tissue of a patient of Figure 6.

Figure 8 is a block diagram of sub procedures of a procedure of the method for treatment of an internal tissue of a patient of Figure 6.

IL291793/ DETAILED DESCRIPTION OF THE EMBODIMENTS The present invention overcomes the disadvantages of the prior art by providing an ultrasound device and method for effectively conveying therapeutic or aesthetic ultrasound and massage treatment to a treated internal tissue of a patient, over prolonged treatment sessions, without harming external tissue layers. The device includes an oscillator and at least one ultrasound transducer coupled with a main body of the device. The transducer is operational to tiltingly rotate at a non-straight (i.e., non-180°) angle against the skin tissue of the patient, while the main body is stabilized at the skin tissue, and to direct non-focused ultrasound energy to a treatment region of the internal tissue underlying the skin tissue.

The terms "user" and "operator" are used interchangeably herein to refer to any individual person or group of persons using or operating the method or system of the present invention, such as a physiotherapist or medical practitioner certified to perform therapeutic and/or aesthetic ultrasound procedures.

The term "patient" is used herein to refer to a person on whom the method or system of the present invention is operated, such as a person undergoing a therapeutic or aesthetic ultrasound procedure.

The term "simultaneous", and any variations thereof, as used herein, also encompasses a period of time before, and a period of time after, the duration under consideration. Accordingly, a first procedure that is described as being performed "simultaneously" to a second procedure, may be performed, IL291793/ e.g., immediately before, immediately after, and/or during the second procedure.

The phrase "component/element X is perpendicular to surface B" as used herein, refers to a substantially 90° angle between an axis which is substantially parallel to surface B and an extended portion of component X which is adjacent to surface B and vertically extends therefrom/thereinto.

Correspondingly, the term "non-perpendicular" as used herein refers to an angle which is not 90° (although is often within a near range of 90°, e.g., 80°, 95°, etc.) between component X and surface B, for example the angle of tilted ultrasound waves propagating through the surface of the skin tissue.

The term "non-straight angle" as used herein refers either to an angle between two touching or nearly-touching substantially flat surfaces which is not 180°, e.g., between the distal surface of a transducer and the skin surface.

Reference is now made to Figure 1A, which is an illustration of an ultrasound device, generally referenced 100, constructed and operative in accordance with an embodiment of the present invention. Reference is also made to Figure 1B which is a cross-sectional illustration of ultrasound device 100 of Figure 1A, taken along a line denoted A-A. Ultrasound device 1 includes a main body 110, a tilting ultrasound transducer 102, a body interface implement 104, an oscillator 106, a motor 120, and an engagement ring 112.

Device 100 is defined as having a distal end and a proximal end, where the distal end faces away from a user (not shown) holding device 100 and is directed towards the body of a patient (not shown), where the distal end is depicted on the bottom of device 100 in Figures 1A and 1B. Main body 110 is IL291793/ disposed at the proximal end of device 100. Tilting ultrasound transducer 1 is positioned at the distal end of main body 110, adjacent to a skin tissue 1 of a patient. Body interfacing implement 104 is a distal component of transducer 102 which interfaces with the treated body part of the patient and through which the ultrasound energy is transmitted thereinto. Oscillator 106 is situated inside main body 110 and is coupled with transducer 102 via a coupling pin 108. Motor 120 is also situated within main body 110 proximally to oscillator 106, and is electrically coupled with oscillator 106. Engagement ring 112 is disposed at the distal end of main body 110 proximally to transducer 102, and radially encircles main body 110 (i.e., about the radial axis). Motor 120 and ring 112 may be considered optional components.

A treated body part of the patient, e.g., an arm, includes an external skin tissue 150 and an internal tissue 160. Skin tissue 150 refers to an outer surface of the patient body which comes in direct contact with transducer 1 during the operation of device 100, and may include one or more skin tissue layers (e.g., epidermis, dermis, and hypodermis). Internal tissue 160 may include any tissue substantially underlying skin tissue 150 which is intended to be energized and treated by transmitted ultrasound waves, including but not limited to: subcutaneous fat tissue (i.e., adipose tissue), muscle tissue, connective tissue, such as ligaments, tendons and bone tissue, and internal organs, e.g., lungs, kidneys, female fertility organs, and the like. Treatment region 162 refers to an approximate region, usually within internal tissue 160, which is regarded to require treatment, and towards which the treatment of device 100 is directed. It is noted that treatment region 162 may be part of a unified collection of tissues adapted for performing a common physiological IL291793/ function, such as a tissue that forms part of an internal organ. Non-limiting examples of types of treatment in which device 100 may be applied include all types of physiotherapeutic treatments, such as treatment of carpal tunnel syndrome, frozen shoulder, tendonitis, ligament injuries, joint tightness, and treatment of internal organs, and various types of aesthetic treatments, such as body sculpting or body contouring processes, face lifting, wrinkle reduction, face and neck skin tightening, and the like. The terms physiotherapy/physiotherapeutic treatment include also all types of medical treatments.

Main body 110 generally has an elongated shape, allowing it to be comfortably gripped by an operator and manually maneuvered to roam over skin tissue 150 of a treated body part. Transducer 102 contacts skin tissue 1 at a tilted or inclined angle and transmits ultrasound waves toward internal tissue 160 underlying skin tissue 150. Oscillator 106 rotates transducer 1 against skin tissue 150 such that transducer 102 moves in a substantially circular motion at the skin tissue 150. Motor 120 powers the rotation of oscillator 106 and the ultrasound transmission of transducer 102. Engagement ring 1 is operational to be selectively extended towards skin tissue 150 and retracted therefrom, as needed.

The operation of ultrasound device 100 will now be described in general terms, followed by specific examples.

When activated, transducer 102 tiltingly rotates at skin tissue 150, continuously pushing against the surface of skin tissue 150 at an inclined angle relative to an axis running parallel to the skin surface. Referring also to Figure 1C, transducer 102 is shaped and/or positioned so as to be in contact with skin IL291793/ tissue 150 at a non-straight angle. An axis parallel to body interface implement 104 forms an angle, designated "α", with an axis parallel to the surface of skin tissue 150. Body interface implement 104 may have a substantially flat panel- like shape, or may have any other surface shape, such as a convex shape, a wave-like shape, etc. When the shape of the body interface plate is not uniformly flat, the angle α may be defined between the tangent to the central portion of the body interface plate and the skin surface. The angle α may be in the range of 0.5°-30°. In some embodiments of the invention the angle α may be in a sub-range of the above range, such as: the range of 1°-20°; the range of 1.5°-15; and the range of 2°-5°. A preferable angle α may be at 3.5°.

Transducer 102 is operated to transmit ultrasound waves 122 while continuously tiltingly rotating in an inclined circular formation. The tilted circular movement pattern of transducer 102 may produce a cyclic-like propagation pattern of the ultrasound waves within the skin tissue. The cyclic propagation pattern may be conically shaped, optionally in a divergent cone shape, such that the narrow end of the cone is created by the ultrasound waves transmitted by transducer 102 at the connection between transducer 102 and skin tissue 150, and the widening end of the cone is created by the propagation of the ultrasound waves within the underlying internal tissue 160. Alternatively, the conical shape may be of a convergent cone, such that the wide end of the cone is created by the ultrasound waves produced by transducer 102 at external skin tissue 150, and the narrowing end is created by the propagation of the ultrasound waves within the underlying internal tissue 160, as will be further described herein with relation to Figures 1F and 1G. Any intermediate conical shapes may also be produced by a movement pattern of transducer 102.

IL291793/ Although the described movement pattern of transducer 102 is in a circular formation, transducer 102 may be alternatively oscillated in diverse movement patterns, such as: a side-to-side pattern, a back-and-forth pattern, a "number 8" formation and the like, or any combination thereof. Therefore, the term "rotate", and grammatical variations thereof, as used herein is to be interpreted broadly to encompass various systematic movement patterns, including circular and non-circular movement patterns. At least one of: the location/position of the ultrasound transducer upon the surface of skin tissue 150 relative to the treated tissue; the magnitude of angle α between the body interface plate of the ultrasound transducer and the skin surface; and the direction toward which angle α is facing, relative to the true north or relative to the patient's body, may dynamically vary during an oscillation cycle of the ultrasound transducer.

For example, when an oscillation pattern of an ultrasound transducer (or of the body interface implement thereof) is a side-to-side tilting, the transducer starts the oscillation cycle in a position at which the angle ( α ) is at a maximal magnitude (in relation to this particular oscillation pattern) and is facing in a first direction relative to the body of the patient (and/or relative to the true north). During the oscillation cycle, the transducer tilts such that the angle ( α ) transfers from facing in the first direction to facing in a second opposite direction, optionally such that the angle ( α ) reaches substantially the same maximal magnitude while facing in the opposite direction. The trajectory of the transducer may be a substantially 2-dimensional (2D) convex trajectory relative to the treated tissue, such that when the transducer is tilting from the maximal angle/tilt on one side to the maximal tilt/angle on the opposite side, the IL291793/ magnitude of the angle ( α ) may gradually decrease until the body interface implement of the transducer is in a substantially straight angle relative to the skin surface, and then may gradually increase until reaching the maximal angle facing in the opposite direction, and so on moving back and forth.

It is noted, that the angled propagation pattern of the ultrasound waves within the tissue, as produced by transducer 102, may optionally be created independently of a tilting movement of the ultrasound transducer, optionally by a non-tilting, i.e., straight-angled, ultrasound transducer. In this embodiment, the oscillator may function as a controller, activating and de-activating various transducers or sections of transducers according to a sequential oscillation pattern. For example, the ultrasound waves may be transmitted from different sections of the transducer (i.e., partial groups of the piezoelectric elements) in a phased array, causing the ultrasound waves to propagate at an angled tilt relative to the tangent of the body interface panel.

Alternatively, particularly when the body interface panel is not flat, the ultrasound waves may be transmitted from different sections of the transducer, in any sequential order, where the diverse angles of the different sections of the body interface panel cause the ultrasound energy to be transmitted, and to propagate within the treated tissue, at respective diverse angles. According to a similar principle, though producing a somewhat opposite effect, the oscillator may be operational to continuously oscillate the ultrasound transducer (i.e., the body interface implement) at/against the skin tissue, such that the angle between the transducer and the surface of the skin tissue is continuously changing (as explained above with relation to transducer 102), and at the same time the oscillator may also continuously alter the sections of the transducer IL291793/ from which the energy is transmitted, such that despite the tilted oscillating of the transducer, the propagation direction of the ultrasound energy may remain substantially unchanged. Any other combination between oscillation of the direction at which the ultrasound energy is transmitted from the transducer, and oscillation of the angle and/or position of the transducer relative to the skin tissue, may be applied. Different oscillation patterns and combinations may even be utilized interchangeably during a single treatment session. Additionally, oscillation of ultrasound waves at skin tissue 150 may be achieved without oscillating an ultrasound transducer along a trajectory or oscillating the transmittal pattern of the ultrasound waves, for example by positioning a plurality of ultrasound transducers at predetermined respective locations on a section of the skin tissue, and/or at predetermined angled tilts relative to the skin tissue, and oscillating the transmitted ultrasound energy by independently activating and de-activating each of the plurality of transducers according to a predefined sequence pattern, controlled and regulated by the oscillator. The alternating activation of the plurality of transducers may be of each transducer in turn, synchronized activating of pairs of opposing transducers, or in any other sequence pattern.

Therefore, where trajectories and movement/propagation patterns of a transducer head and/or of ultrasound waves is described herein, the option of producing a corresponding effect using alternative methods is to be considered incorporated by reference, including utilizing a plurality of stationary ultrasound transducers, transmitting ultrasound waves from partial sections of the ultrasound transducer, or any other method known in the art for manipulating ultrasound waves.

IL291793/ The oscillation at a tilted angle of transducer 102 produces a massaging effect at skin tissue 150, which may improve blood flow and circulation of the lymph system in the underlying internal tissue 160. This tilting oscillation may make it difficult to maintain transducer 102 in a desirable position and in close contact with skin tissue 150, in order to effectively deliver energy to the underlying internal tissue 160. Main body 110 may therefore be shaped and sized so as to facilitate its stabilized positioning at skin tissue 1 by an operator, and so by extension to stabilize the activated transducer 1 and maintain the position of transducer 102 at skin tissue 150 while tiltingly rotating. The shape of main body 110 may include, for example, an elongated shape, a spherical shape, may include a protruding handle, and/or any other shape which allows an operator to maintain main body 110 at a substantially fixed and steady alignment relative to the surface of skin tissue 150. In one embodiment of the invention, main body 110 may be aligned substantially perpendicular to skin tissue 150, i.e., such that the angle between the longitudinal axis of the main body 110, and an axis parallel to skin tissue 150, is substantially 90°. However, the alignment of main body 110 relative to skin tissue 150 may vary, and may include, for example, a straight angle, a 45° angle, and/or may be adjustable according to the body part needed to be treated.

Reference is now also made to Figure 1D, which is an illustration of device 100 shown from its distal end, depicting a movement pattern of the tilting rotation of transducer 102. Reference is also made to Figure 1E, which is an illustration of device 100 and an energized area 170 of the body part, which receives ultrasound energy transmitted by transducer 102. Transducer 102 IL291793/ tiltingly rotates along movement pattern 172 at skin tissue 150. The angle α between transducer 102 and skin tissue 150 (shown in Figure 1C), and the rotation of transducer 102, cause the distal surface of transducer 102, referenced herein as transducer surface 103, to continuously and successively travel over a section of skin tissue 150, referenced herein as transducer contact section 154. Transducer contact section 154 includes an area of skin tissue 1 with which transducer surface 103 makes contact in a full rotation/oscillation cycle, when device 100 is stationary. The area of section 154 is therefore larger than the area of transducer surface 103. The area of section 154 is usually in direct proportion to angle α , i.e., a larger angle α between transducer 102 and skin tissue 150 will usually produce a larger area of section 154. However, the shape and area of section 154 are also dependent upon the general shape of transducer 102 and the movement pattern of transducer 102 at skin tissue 150.

Transducer 102 transmits non-focused ultrasound waves 122 while tiltingly oscillating, to be directed in a continuous sweeping pattern toward an internal tissue section 164 of internal tissue 160, underlying section 154 of skin tissue 150. The frequency of the ultrasound waves transmitted by at least one transducer 102 may be in the range of 0.5-4.5 MHz, and the ultrasound intensity may be in the range of 0.1-3.5 W/cm2. Mainly due to the angled direction at which ultrasound waves 122 are transmitted, internal tissue section 164 is of broader scope than section 154 against which transducer 102 is rotating, i.e., transducer 102 delivers energy to a broad area of internal tissue 160, the periphery of which does not necessarily lie directly beneath its point of contact with skin tissue 150. This is also partially due to the divergence of ultrasound waves 122 as they penetrate deeper into the tissue.

IL291793/ For example, when the radius of transducer 102 is approximately R(transducer)=2 cm, transducer 102 is tilted at angle α =3.5°, and transducer 1 rotates in a substantially circular pattern against skin tissue 150, the resultant underlying internal tissue section 164, at a depth of about 5 cm beneath the surface of skin tissue 150, has a radius of about R(deep section)=3 cm. In other words, the area of internal tissue section 164 which is energized by transducer 102, is more than twice as large as the area of transducer surface 103.

The tilting movement pattern of transducer 102, which causes an increase of radius/area of transducer contact section 154 relative to transducer 102, and of internal tissue section 164 relative to transducer contact section 154, may allow increased delivery of ultrasound energy to the internal tissue (160) while reducing the exposure of external skin tissue 150 to high energy ultrasound, as compared with a straight-angled (i.e., non-tilted) ultrasound transducer. Throughout the tilting rotation of transducer 102, the region of external skin tissue 150 with which transducer 102 is making direct contact, within the transducer contact section 154, is continuously altered (as is evident from the area of section 154 being larger than the area of transducer 102). This helps prevent prolonged exposure of any one portion of external skin tissue 1 to high frequency ultrasound while ultrasound device 100 is stationary at a particular location of external skin tissue 150, allowing ultrasound device 1 to remain at that particular location for longer than would be possible with a parallel ultrasound transducer without causing damage to the external skin tissue. Ultrasound device 100 remaining stationary at a particular location for a longer time period allows increased energizing of the underlying internal tissue section 164, which enhances the effectivity of the ultrasound treatment.

IL291793/ Furthermore, as internal tissue section 164 has a relatively large area compared to transducer contact section 154, when device 100 (including transducer 102) is advanced from a first particular location to a following adjacent location of external skin tissue 150, at least part of a first internal tissue section 164, which underlies the first particular location, will continue to receive ultrasound energy when device 100 is positioned in the following adjacent location (i.e., a following internal tissue section 164, which underlies the following adjacent location of device 100, will partially overlap with the first internal tissue section 164) further enhancing the energizing of internal tissue 160.

From another perspective, the angled tilting of ultrasound transducer 102 may also enhance the massaging effect produced by the transducer, by applying a deeper and more diverse physical massage to skin tissue 150 as compared with the massage applied by a rotating transducer that rotates flatly against the skin tissue. The shifting angle of ultrasound transducer 102 may cause transducer 102 to contact different portions of the skin tissue against which it is rotating and at varying angles, and the angular inclination of transducer 102 may cause transducer 102 to press more deeply against skin tissue 150, particularly at the distal end of the tilting transducer 102.

It is noted, that some possible advantages of internal tissue section 164 having a larger area than transducer contact section 154 have been described above. However, a larger section 164 is the case only in some rotation patterns of tiltingly rotatable ultrasound transducer 102, while other rotation patterns may have other advantages with regard to effective energy delivery to the internal tissue. For example, with reference to Figure 1F and IL291793/ Figure 1G, ultrasound transducer 182, of ultrasound device 180, is tiltingly rotated along substantially circular trajectory 184, such that in a full cycle of rotation transducer 182 makes contact with external skin tissue 150 in the area of skin tissue designated transducer contact ring 194. In the center of ring 1 is a section of skin tissue 150 with which transducer 182 does not make any contact, when ultrasound device 180 is stationary at a particular location. While tiltingly rotating, transducer 182 emits ultrasound waves 192 toward the underlying internal tissue. Due to the angular tilt and rotation pattern of transducer 182 it contacts each point on external skin tissue 150 only once during each full rotation cycle, and ultrasound waves 192 energize a relatively concentrated internal tissue section 196 (which may have a smaller total area than transducer contact ring 194). The large area of contact ring 194 allows prolonging the time that ultrasound device 180 is maintained (i.e., is substantially stationary) at a particular location of skin tissue 150 while having a substantially reduced risk of causing damage to external skin tissue 150, as each point of skin tissue 150, after receiving direct ultrasound energy from transducer 182, then has an intermission from receiving direct energy for the remainder of the rotation cycle of transducer 182, before receiving another energy dosage. The effectivity of ultrasound treatment depends upon a sufficient quantity and/or duration of energizing of the internal tissue, and these are often compromised by the need to shift the location of the transducer so as not to damage the external skin tissue. Prolonging the stay of ultrasound device 180 at a single location, with a reduced risk of damage, together with the relatively concentrated internal tissue section 196 of ultrasound waves 192, may produce an increase in the length of time and the quantity of energy being IL291793/ delivered to the internal tissue, and may therefore enhance the effectivity of the energizing of the internal tissue.

As exemplified in the above (Figures 1A-1G), an ultrasound device may display any variety of angular tilts and oscillation patterns of the at least one ultrasound transducer which may each be individually advantageous to effectively energizing a body tissue. The common and essential feature is that the ultrasound transducer transmits ultrasound energy at non-perpendicular, angle relative to the skin tissue in a least a part of the oscillation cycle (of course, the transmitted ultrasound may be perpendicular to the skin tissue in parts of the oscillation pattern), and that the direction, angle, and/or position at which the ultrasound is transmitted and propagates within the skin tissue is oscillated.

Referring back to Figures 1A and 1B, Oscillator 106 is operational to rotate in a plane which is substantially parallel to skin tissue 150, and is coupled with transducer 102 such that the parallel rotation of oscillator 106 initiates the tilting rotation of transducer 102. Oscillator 106 may be directly attached to transducer 102, or may be coupled through a coupling element, e.g., coupling pin 108. For example, coupling pin 108 may be linearly continuous to the proximal end of transducer 102 and may be attached to the outer circumference of rotor 106, so as to form a relative angle between transducer 102 and oscillator 106. The rotation of transducer 102 is powered, via oscillator 106, by motor 120 but may alternatively be powered by an alternative powering mechanism, such as a mechanical mechanism, e.g., a winding spring, or manually by an operator. The ultrasound transmission of transducer 102 may also be activated by motor 120, or activated by a separate motor (not shown).

IL291793/ Engagement ring 112, which encompasses transducer 102, is operational to be selectively extended in a distal direction toward skin tissue 150 during the operation of transducer 102, such that ring 112 tightly engages skin tissue 150 in close perpendicular contact, while transducer 102 tiltingly rotates in an inclined circular formation against section 154 of skin tissue 150, enclosed by ring 112. The tight engagement of ring 112 with skin tissue 1 may help stabilize the positioning of device 100 upon skin tissue 150, and allow transducer 102 to maintain close contact with skin tissue 150 despite the tilting rotation thereof. Although in the present embodiment of the invention transducer 102 is substantially aligned with main body 110, transducer 102 may alternatively be positioned anywhere in the vicinity of main body 110 and coupled thereto.

Treatment with device 100 may be administered by an operator who grasps main body 110 and manually maneuvers device 100 over skin tissue 150, for effectively energizing a broad portion of internal tissue 160 which surrounds treatment region 162 of the treated body part. In conducted experiments it has been found that the effectivity of treatments administered with existing rotatable ultrasound devices as known in the prior art, where the rotating transducer is parallel to the skin tissue, were significantly more effective when the operator had been trained to manually tiltingly maneuver the device against the skin tissue of the patient, particularly rotating the device in an inclined circular formation. However, training an operator to tiltingly rotate the ultrasound transducer during treatment, so as to achieve the desired effect, requires a full month of training. Moreover, it is a physically demanding procedure and operators are usually unable to administer this type of treatment IL291793/ for the duration of a full treatment session, let alone for an entire day of therapy.

Accordingly, the ultrasound device of the present invention, which automatically tiltingly rotates the ultrasound transducer and reduces the skill and effort required of the operator to a minimum, has been found to be substantially advantageous over existing ultrasound treatment devices, producing measurable therapeutic/aesthetic results from the very first treatment session, performed even by an unexperienced operator. Importantly, the substantial benefits of maneuvering the transducer in a tilting rotation during treatment is a new discovery, and is not common knowledge in the art, as can be seen for example in user manuals of leading companies in the field of physiotherapeutic ultrasound devices. See for example: https://www.mettlerelectronics.com/wp- content/uploads/740_manual.pdf, page 28. The tilted oscillation pattern of transducer 102 may induce an altering stimulation to the different layers of the skin tissue, compared to the substantially fixed stimulation caused by a transducer which rotates flatly against the skin tissue, due to the continuously changing angle at which the ultrasound is being transmitted into the skin tissue.

This alteration may restrict, slow or prevent a rise in skin impedance which usually results from continuous ultrasound stimulation, the rise in impedance often causing the ultrasound waves to propagate less effectively within the skin tissue and to lose their effectivity. Preventing or slowing the rise in skin impedance may enhance the energy delivery to internal tissue 160 by transducer 102, which may result in a more effective treatment.

An ultrasound device of the present invention may be configured to be automatically attached to the skin tissue of the patient, removing the need for an operator to constantly hold the device in position. Reference is now made IL291793/ to Figure 2, which is an illustration of an ultrasound device 200 including multiple stabilizing arms 230, constructed and operative according to the present invention. Stabilizing arms 230 are "L"-shaped, such that the tip of the short arm of the "L" of each of stabilizing arms 230 is coupled at a proximal end with main body 210 of device 200, and the tip of the of each of stabilizing arms 230 is coupled at a distal end with skin tissue 150. Adjustment springs 234 are disposed within the long arm of the "L" of each of arms 230. Engagement ring 212, which encompasses ultrasound transducer 202, is coupled with a plurality of suction units 214 at the distal end of ring 212. Distal transporters 232 are coupled to the distal end of stabilizing arms 230, and are configured to enhance the maneuverability of device 200 over skin tissue 150.

Stabilizing arms 230 are operational to stably position and/or couple ultrasound device 200 to skin tissue 150. Arms 230 may be composed of a rigid material, such as metal, plastic and the like, and may include an adjustment mechanism, such as springs 234, for adjusting the length of stabilizing arms 230 and/or the position of arms 230 in relation to main body 210 and/or skin tissue 150, when device 200 is maneuvered over skin tissue 150. Particularly, when device 200 is applied and maneuvered over a skin tissue which is not flat and uniform, e.g., the circumference of an arm, springs 234 may compress and decompress according to the changing skin surface. This may allow maintaining the stability of arms 230 upon skin tissue 150, and by extension, maintaining the stability of main body 210 while travelling over the un-even surface of skin tissue 150. Device 200 may include one or more stabilizing arms 230, such that when there is a plurality of arms 230 they may be distributed around the circumference of main body 210 at substantially equal distances, or IL291793/ in any other distribution which balances and stabilizes main body 210 on skin tissue 150. For example, when device 200 includes two stabilizing arms 2 they may be positioned at opposing sides of main body 210. The positioning of arms 230 may also be adjustable, for example by installing the proximal end of arms 230 into a groove (not shown), bored along the circumference of main body 210, inside which groove the proximal end of arms 230 can be maneuvered so as to adjust the position of arms 230 relative to main body 210.

The stability which arms 230 lend to main body 210 may allow coupling and automatically maneuvering device 200 over skin tissue 150 of a treated body part, without the need of an operator. Distal transporters 232, coupled to arms 230, may be powered by a motor to advance device 200 over skin tissue 150. The trajectory of device 200 travelling over skin tissue 150 by transporters 232 may be controlled by an operator by remote control, or may be predefined. Distal transporters 232 may include for example wheels, tracks, or any other transporting means. Transporters 232 may be coupled to stabilizing arms 230, main body 210, and/or to any other component of device 200. When the ultrasound device is maneuvered by an operator it is challenging for the operator to constantly maintain the device at a precisely correct pressure against skin tissue 150 and to advance the device at the precisely correct advancement rate along skin tissue 150, such that the ultrasound energy will be delivered most effectively without causing damage, particularly for prolonged treatment periods. Therefore, attaching device 200 to external skin tissue 150 using arms 230 and automatically maneuvering device 200 over skin tissue 150 with transporters 232 may be particularly advantageous in IL291793/ maintaining an optimal pressure and advancement rate of transducer 202 at external skin tissue 150.

Suction units 214 are operational to apply a suction force to skin tissue 150. Applying vacuum suction to a tissue as a form of massage may be utilized in addition to the massaging effect of transducer 202. Moreover, suction units 214 may improve the coupling and/or stability of device 200 at the treated body part. Specifically, if at least one suction unit 214 is coupled to the distal end of ring 212 it may, when activated, enhance the tight engagement of skin tissue 150 by engagement ring 212, so as to fixate ultrasound device 200 onto the treated body part and subsequently stabilize transducer 202 while tiltingly rotating at skin tissue 150. Suction units 214 may alternatively be coupled to stabilizing arms 230, distal transporters 232, main body 210, and/or any other part of device 200. As will be further explained with reference to Figure 4, during a treatment session of a body part, ultrasound device 200 is usually slowly maneuvered over skin tissue 150. The slow maneuvering of ultrasound device 200 usually involves lingering for a brief duration, such as approximately 1- seconds, at a selected region of skin tissue 150 before continuing to the next adjacent region, in order to allow effective absorption of ultrasound energy in the internal tissue. At least one suction unit 214 may be activated to apply a suction force upon arrival at a particular location of skin tissue 150, for fixating ultrasound device 200 thereto, and may be deactivated after 1-3 seconds so as to disconnect from skin tissue 150 and allow advancing ultrasound device 2 to a subsequent location of skin tissue 150.

In order for transmitted ultrasound waves to reach internal tissue 1 at an effective energy level, the transducer, which is applied at the skin tissue IL291793/ 150, should transmit ultrasound waves with an energy level substantially higher than the effective energy level, which higher energy level is harmful to the skin tissue at prolonged exposures. One way to overcome this obstacle is by utilizing the effect of constructive interference. Constructive interference is the combining of at least two ultrasound waves which are incident at a particular location and in phase, i.e., at their wave energy maxima, so as to produce an amplitude, i.e., energy level, which is the vector sum of the amplitudes of the at least two ultrasound waves. Energizing internal tissue 160 by coordinating the transmittal of ultrasound waves to produce constructive interferences therein, allows applying lower energy ultrasound at the skin tissue and, as a result, allows longer and more effective energizing.

With reference to Figure 3A, ultrasound device 300 includes a plurality of tilting ultrasound transducers 302, for rotating at skin tissue 1 while transmitting ultrasound energy thereto. Each of transducers 302 is coupled with main body 310 and is positioned to contact and rotate at skin tissue 150. Engagement ring 312 encompasses transducers 302 and may be selectively extended to forcefully push against skin tissue 150 so as to stabilize transducers 302 when they rotate at skin tissue 150. A plurality of electrodes 326 are coupled with device 300 and configured to deliver electrical stimulation to skin tissue 150. Transducers 302 may rotate independently of each other or in a synchronized manner. At least two of transducers 302 are positioned in an orientation and position relative to each other, which coordinates the propagation into the skin tissue of ultrasound waves 322, transmitted by the at least two transducers 302, to combine and produce a constructive interference within internal tissue 160. The Referring also to Figure 3B, angular oscillating IL291793/ of at least one tilting ultrasound transducer 302 shifts the location of the constructive interference within internal tissue 160. The angular tilting rotation of the at least one of transducers 302 causes transmitted ultrasound waves 3 to propagate in a sweeping pattern, e.g., in a substantially circular or cyclic pattern, within internal tissue 160. The propagation of ultrasound waves 3 causes a successive variation of the combinations between ultrasound waves 322 which are transmitted by the plurality of transducers 302, and provides a continuous shifting of the locations within internal tissue 160 at which the constructive interference is produced. The oscillation, and direction of ultrasound transmission, of at least two of transducers 302 may be coordinated to create a constructive interference pattern in the internal tissue 160. Shifting the locations of the constructive interference may thoroughly energize the internal tissue treatment region 162 which substantially underlies the location of ultrasound transducers 302 on external skin tissue 150, enhancing the effectivity of the ultrasound delivery to treatment region 162 and possibly allowing to shorten the treatment duration. While at least one of transducers 302 is operational to tiltingly rotate when activated, at least another one of transducers 302 may be a non-tilting ultrasound transducer, i.e., may be operational when activated to transmit ultrasound energy towards internal tissue 160 while rotating at skin tissue at a straight (i.e., non-tilting) angle.

Electrical stimulation may also be applied to skin tissue 150 by electrodes 326 so as to improve propagation of transmitted ultrasound waves 322 toward internal tissue 160. At least one electrode 326 may be positioned on skin tissue 150, operational to electrically stimulate skin tissue 150.

Electrodes 326 may be coupled to ultrasound device 300 and a controller (not IL291793/ shown) may regulate the activation and electrical parameters of electrodes 326.

Alternatively, electrodes 326 may be components of an independent electrical stimulation apparatus, and together with device 300 and a controller may make up a treatment system. Additional features of the treatment system may include, for example: an impedance monitor, a diagnostic imaging device, and the like.

Combining the electrical stimulation of at least two electrodes 326 may produce an interferential stimulation to skin tissue 150, which stimulation can reduce, maintain substantially constant, or otherwise change the impedance of the treated tissue in general, and of the in particular. Ultrasound treatment of a body tissue has been found to cause a change (usually a rise) in the impedance of the treated body tissue, which occurs after only several minutes of ultrasound treatment, the result of which is a decrease in the penetration of the ultrasound energy and reduced effectivity of the treatment. Lowering, maintaining constant, or otherwise altering the tissue impedance, by virtue of electrical stimulation of the body tissue by electrodes 326, may enhance propagation and promote deeper advancement of ultrasound waves 322 into the treated tissue, without having to raise the energy level of ultrasound waves 322. Electrodes 326 may be independent of ultrasound device 300, electrically coupled with device 300, and/or installed upon components of device 300, e.g., engagement ring 212 and/or transducers 302. For example, ultrasound device 300 may include 4 transducers 302 which each include an electrode 326, such that the electrical stimulation applied by the 4 transducers 302 generates an interferential beat frequency within the tissue region encompassed by transducers 302. As another example, an electrical stimulation produced by at least one electrode 326 positioned externally to ultrasound device 300 may IL291793/ interact with electrical stimulations produced by electrodes 326 of transducers 302 to generate interferential beat frequency to the tissue region lying between them. Further details regarding the parameters, recommended treatment plan, physiological effects, and benefits of interferential electrical stimulation treatment may be found, for example, in U.S. Patent No. 9,345,909 B2 to Ilan Feferberg, entitled "Skin Ulcer Treatment" (2016). The types of electrical stimulation applied by electrodes 326 may also include transcutaneous electrical nerve stimulation (TENS) and/or high voltage stimulation.

At least two transducers 302 may be linked to form an integrated transducer unit 308. Transducer unit 308 may be oscillated by at least one oscillator 306. The oscillating of integrated transducer unit 308 at skin tissue 150 maneuvers transducers 302 over skin tissue 150 in a substantially circular motion, i.e., in a circular shaped trajectory, while the movement of each of transducers 302 corresponds to the movement of unit 308. The oscillating of integrated transducer unit 308 may maneuver transducers 302 in other movement patterns, e.g., sided-to-side, a "number-8-shaped" trajectory, and the like. Alternatively, the plurality of ultrasound transducers 302 may each be configured to be oscillated independently when device 300 is substantially stationary at a particular location of skin tissue 150. The circular rotation or other movement patterns of transducers 302, when device 300 is positioned at a particular location of skin tissue 150, may serve several purposes: firstly, the changing of position of transducers 302 shifts the locations at which constructive interference is produced within the internal tissue 160, further enhancing the thorough energizing of internal tissue treatment region 162.

Secondly, the continuous movement of transducers 302 over skin tissue 150 IL291793/ decreases the exposure of any one area of skin tissue 150 to high energy ultrasound. For example, if the gap (i.e., distance) between a plurality of transducers 302 is equal to the width of each of the transducers 302, in relation to the circumference of integrated transducer unit 308 into which transducers 302 are integrated, the rotation of unit 308 will allow each area of skin tissue 150 to alternate between equal time periods of exposure to high energy ultrasound, and rest therefrom. This may substantially lower the risk of damaging skin tissue 150 by prolonged exposure to high energy ultrasound, while allowing more prolonged ultrasound transmission toward the underlying internal tissue 160. Moreover, the continuous rotation of the integrated transducer unit 308, or the independent movement patters of transducers 302, may produce an additional massaging effect to the skin tissue 150 and underlying tissue layers.

The tilting oscillating of the ultrasound transducers is advantageous to enhancing energy delivery to a particular, relatively broad, internal section (164) of the internal tissue 160, which underlies the ultrasound device, while reducing the exposure of the corresponding skin tissue 150 to direct high energy ultrasound. In order to effectively energize an extensive portion of internal tissue 160 which encompasses the treatment region 162, while protecting skin tissue 150 from exposure to excessive ultrasound energy, the ultrasound device may be continuously maneuvered over skin tissue 150.

Reference is now made to Figure 4, which is an overhead view illustration of the trajectory along which ultrasound device 400 is maneuvered over skin tissue 150. Device 400 is systematically maneuvered over skin tissue 150, either manually or automatically as explained with reference to Figure 2, so as IL291793/ not to miss any area of skin tissue 150, and correspondingly any area of internal tissue 160. The trajectory for systematic maneuvering of device 400 may include, for example: a back and forth trajectory 158, in which device 4 alternatingly travels in a forward direction 182 and a backward direction 1 over skin tissue 150, while advancing in sideways direction 186; a coiled spring trajectory 159, in which device 400 travels in circles, which are substantially broader than the circular pattern of the rotatable ultrasound transducer 402, while advancing in forward direction 182 and/or backward direction 184 over skin tissue 150; and/or any other trajectory which thoroughly covers the area of skin tissue 150 which overlies treatment region 162.

By virtue of the tilting rotation of ultrasound transducer 402 against skin tissue 150, as opposed to the perpendicular contact and straight angle rotation as in the accepted practice, device 400 may possibly be applied at any one location on of skin tissue 150 for more prolonged time periods. The angled tilt of transducer 402 causes transducer 402, when rotating, to alternatingly and sequentially contact partially different points of the skin surface, and this may reduce the continuous exposure to high ultrasound energy at any given portion of skin tissue 150.

Reference is now made to Figure 5, which is an illustration of a measurement assembly designated 500, for measuring bodily parameters of a patient (502) who has been treated with an ultrasound device for adjusting body shape parameters, such as body sculpturing of the abdomen, thighs, arms and the like, to track the effectivity of the treatment. Measurement assembly 5 includes an imaging device 510, a green screen 512, a plurality of scale markers 514, a designated box 516, a processor 520 and a display screen 522.

IL291793/ Patient 502 stands erect in front of imaging device 510 within designated box 516. Box 516 is adjacent to green screen 512 which serves as a background of patient 502 in the images which are captured by imaging device 510. Scale markers 514 are positioned in fixed locations, and form a substantially two- dimensional plane (518) which encompasses patient 502 and is parallel to green screen 512 and to the lens of imaging device 510. Although there is an advantage to the sensors creating a 2-D plane, scale markers 514 may be positioned to form only a one-dimensional plane (i.e., two sensors forming a straight line parallel to the ground) and the 1-D or 2-D plane may not encompass patient 502. Images of patient 502 are captured by imaging device 510 and the imaging data is supplied to processor 520. Processor 5 processes the supplied imaging data, the processing usually including the following steps: 1) calculating a pixel/actual-length scale of the supplied image (e.g., pixel/cm and the like), by measuring the number of pixels between each pair of scale markers 514, and dividing the measured number by the actual distance between the scale markers, which is predefined in processor 520; 2) cancelling the image content of the pixels within the image which depict green screen 512; 3) measuring the number of pixels within a plurality of spaced-apart parallel torso lines 524 (i.e., parallel to each other and to the ground) which span the torso of patient 502 as depicted by the imaging device, the limits of the torso being identifiable in contradiction to the now empty green screen pixels; 4) converting the measured number of pixels of lines 524 into a length measurement of lines 524 according to the calculated pixel/Cm scale; 5) storing the length measurements within processor 520 for further analysis, and/or providing the length measurements for an operator of measurement assembly IL291793/ 500. Optionally, if the absolute length of the torso of patient 502 is not required and only the change in torso length is required relative to an initial baseline, the measurement/predefinition of the actual distance of scale markers 514 and the conversion of measured pixels to actual length may not be necessary. The imaging data which is captured by imaging device 510 and provided to processor 520 may be presented upon display screen 522, and may preferably be presented after being processed by processor 520, such that only patient 502 and parallel torso lines 524 are shown on display screen 522. An operator may control which torso lines to present and which measurements to display on screen 522. The operator may also be able to select a line, or two points, upon the torso of patient 502 as displayed upon screen 522, and processor 5 may be operational to perform measurements of the line (or lines) selected by the operator. These selected lines may be in any shape and relation to each other, and not necessarily straight parallel lines.

Following a treatment session of patient 502 using an ultrasound device, the body part of patient 502 which underwent the body shaping treatment may be subjected to evaluation using measurement assembly 500.

The measurement may be performed at any time ranging from immediately after the treatment session to several months after the treatment, for follow up.

A plurality of images of patient 502 are usually captured, with patient 502, or the treated body part thereof. Being positioned at a variety of angles (e.g., front view, hind view, side view, etc.) allowing processor 520 to measure the treated body part of patient 502 (e.g., using torso lines 524) from different angles, which give a good indication of the shape of the treated body part and the change thereof. The measurements of the treated body part by processor 520 are not IL291793/ limited to parallel torso lines 524, and any other image analysis may be performed by processor 520 to give an indication of the body shape and dimensions of patient 502, and the change of the shape and/or dimension following treatment. Also, other sensors may be applied to measure the dimensions of patient 502, such as radar sensors, measuring the distance from a radar source to each selected point on patient 502 which may give a good indication of the girth of patient 502, or any other relevant sensors. The information acquired by the sensors and processed by processor 520 may all be saved for patient management and analysis. And tracking of the patient treatment process.

Reference is now made to Figure 6, which is a block diagram of a method for applying treatment of an internal tissue of a patient, operative in accordance with an embodiment of the present invention.

In procedure 602, an ultrasound device is provided. The device includes an oscillator and at least one tilting ultrasound transducer coupled with a main body of the device. Referring for example to Figures 1A and 1B, ultrasound device 100 includes main body 110, tilting ultrasound transducer 102, body interface implement 104, and oscillator 106. Oscillator 106 may be powered by a motor 120 and tiltingly rotates transducer 102 at skin tissue 150.

In procedure 604, a treatment session is initiated. Referring to Figure 1B, an operator (not shown) initiates a treatment session of a patient to apply a therapeutic and/or aesthetic ultrasound and massaging treatment to an internal tissue 160 of the patient.

In procedure 606, the ultrasound transducer is deployed onto a skin tissue overlying a treatment region of an internal tissue of the patient, such that IL291793/ a body interface implement of the tilting ultrasound transducer interfaces with the surface of the skin tissue. Referring for example to Figures 1A-1C and Figure 2, transducer 102 is positioned on skin tissue 150, overlying treatment region 162 of internal tissue 160, such that body interface implement 1 interfaces with the surface of skin tissue 150. Main body 110 is stabilized at skin tissue 150, e.g., being maintained in a substantially perpendicular angle relative to skin tissue 150, and may be shaped so as to be comfortably gripped by an operator. Engagement ring 112 may be extended towards skin tissue 1 to surround transducer 102 and tightly engage skin tissue 150. At least one stabilizing arm 230 may be coupled with main body 110 to allow stable positioning of device 100 upon skin tissue 150 without the need of an operator.

In procedure 608, the tilting ultrasound transducer is induced to transmit ultrasound energy onto the skin tissue, and the oscillator is activated to oscillate, relative to the surface of the skin tissue, at least one of: the position of the body interface implement; the tilt direction of the body interface implement; and the propagation direction of the ultrasound energy, which may be tilted respective of the surface of skin tissue 150 at a non-perpendicular angle at least during part of an oscillation cycle. Referring for example to Figures 1A-1G, 2, 3A and 3B, at least one tilting ultrasound transducer 102 is induced to transmit ultrasound energy toward Internal tissue 160 including treatment region 162. Transducer 102 may be activated by motor 120.

Oscillator 106 may also be activated by motor 120, and oscillates at least one of: the position/location of body interface implement 104 upon the surface of skin tissue 150; the direction of the tilt of body interface implement 104, relative to the patient or to the true north; and the propagation direction of the ultrasound IL291793/ energy within the treated tissue of the patient. Ultrasound device 300 includes a plurality of transducers 302 which may be activated in a coordinated manner to transmit ultrasound waves 322 to produce a constructive interference within internal tissue 160. The plurality of transducers 302 may form an integrated transducer unit 308, which transducer unit 308 may be oscillated at skin tissue 150. Electrodes 326 may be applied to create an electrical stimulation at skin tissue 150, and particularly an interferential electric field therein. Suction units 214 may also be applied to create a suction force upon skin tissue 150, enhancing the coupling and stabilizing of ultrasound device 100/200 at external skin tissue 150.

In procedure 610, the main body of the device is maneuvered to roam over the skin tissue, so as to direct ultrasound energy toward an extensive portion of the treatment region of the internal tissue. Referring for example to Figures 1B, 2 and 4, ultrasound device 400 is maneuvered over skin tissue 1 in order to deliver ultrasound energy to an extensive portion/section of internal tissue 160 encompassing treatment region 162. Device 400 may be manually maneuvered by an operator grasping main body 110, or automatically maneuvered by motor 220, specifically when device 200/400 includes at least one stabilizing arm 230 and transporters 232. Device 400 may travel along back and forth trajectory 158, coiled spring trajectory 159, or any other trajectory which effectively directs energy to the extensive portion of the treatment region 162.

In procedure 614 (after ending the treatment session), the body- shape parameters of the treated tissue of the patient are measured, using a measurement assembly including an imaging device, a green screen, and scale IL291793/ markers, to track the effect of the treatment on the patient. Referring for example to Figure 5, patient 502 stands in front of green screen 512 and is photographed by imaging device 510, usually at several angles (front view, side view, etc.). Processor 520 receives the images taken by imaging device 5 (and/or by data provided by other sensors) and processes the images, such as by using scale markers 514 to create a pixel/length scale, and measures and/or calculates body-shape parameters of the treated body part of patient 502.

Reference is now made to Figure 7, which is a block diagram of sub- procedures of procedure 608 of the embodiment of Figure 6. In procedure 616, the oscillator dynamically changes transmittal direction of the ultrasound waves relative to the body interface implement. Referring to Figures 1B and 1E, an oscillator (not shown) oscillates the direction at which the ultrasound waves are transmitted from the ultrasound transducer 102, relative to body interface implement 104 (specifically, relative to a tangent to the central portion of body interface implement 104), optionally by controlling and regulating the activation and de-activation of the different sections of the ultrasound transducer to produce ultrasound waves in a particular sequence and/or in a phased array.

In procedure 618, the oscillator respectively activates and deactivates each of a plurality of ultrasound transducers, positioned on the skin tissue, according to a sequence pattern. Referring to Figures 1F, 1G, 3A and 3B, oscillator 106 activates and deactivates each of a plurality of ultrasound transducers 102/302 positioned on skin tissue 150 in respective positions, to transmit ultrasound energy according to a sequence pattern regulated by the oscillator.

IL291793/ In procedure 620, the tilting ultrasound transducer forms a non- straight tilting transducer angle between an axis parallel to the body interface implement and an axis parallel to the skin surface, and the oscillator dynamically changes the magnitude and/or direction of the tilting transducer angle while massaging the skin tissue. Referring to Figures 1A-1G, 3A and 3B, tilting ultrasound transducer 102 is deployed such that body interface implement 104 forms an angle α with skin tissue 150, and oscillator 1 oscillates the transducer such that the magnitude of angle α and/or the direction in which angle α is facing dynamically changes. The dynamic changing of angle α may cause the propagation direction of the ultrasound energy within the internal tissue to form a divergent conic-like pattern, a convergent conic-like pattern, or any other sweeping energy pattern, depending on the trajectory along which body interface implement 104 is oscillated and the respective transmittal direction of the ultrasound energy. In some oscillation patterns, transducer 102 energizes an underlying internal section 164 of internal tissue 160 which is broader than section 154 of the surface of skin tissue 150 against which transducer 102 is rotating. The oscillating of body interface implement 104 of transducer 102 also applies massage to skin tissue 150.

Reference is now made to Figure 8, which is a block diagram of sub- procedures of procedure 614 of the embodiment of Figure 6. In procedure 622, a pixel-to-actual-length scale of a captured image is calculated by measuring the number of pixels between at least two scale markers, and dividing the measured number by the actual distance between the scale markers. Referring to Figure 5, processor 520 measures the number of pixels between at least two scale markers 514 within an image captured by imaging device 510, and divides IL291793/ the measured number of pixels by the actual length between scale markers 514, which may be predefined in processor 520, producing a scale of pixel/actual-length for the captured image.

In procedure 624, the image content of the pixels which depict green screen background within the captured image is cancelled, i.e., erased or eliminated, by the processor. Referring to Figure 5, processor 5 cancels/erases the image content from the pixels in the capture image which represent green screen 512.

In procedure 626, the number of pixels is measured within torso lines of the treated body part of the patient, the torso lines spanning the length and/or breadth of the treated body part in the captured image. Referring to Figure 5, processor 520 measures the number of pixels in each of torso lines 524, which span the length and/or breadth of the treated body part of patient 502.

In procedure 628, the measured number of pixels if the torso lines is converted into an actual length measurement of the torso lines, using the scale which was calculated in Procedure 616. Referring to Figure 5, processor 5 converts the measured number of pixels in each of torso lines 524 into an actual-length measurement of torso lines 524, using the pixel/actual-length scale which was calculated for the captured image.

In procedure 630, the actual-length measurement of the torso lines is stored within the processor, and/or is provided for an operator of the measurement assembly. Referring to Figure 5, processor 520 stores the actual- length measurements of torso lines 524 of treated body part, and/or provides them for an operator of measurement assembly 500, for tracking the effect of the treatment with an ultrasound device on patient 502.

IL291793/ While certain embodiments of the disclosed subject matter have been described, so as to enable one of skill in the art to practice the present invention, the preceding description is intended to be exemplary only. It should not be used to limit the scope of the disclosed subject matter, which should be determined by reference to the following claims.

Claims

IL291793/ CLAIMS

1. A system for therapeutic and/or aesthetic ultrasound treatment, the system comprising: an ultrasound device comprising: at least one tilting ultrasound transducer, comprising a body interface implement, the tilting ultrasound transducer configured to be deployed and transmit ultrasound energy onto a skin tissue overlying a treatment region of an internal tissue of a treated body part, such that the body interface implement interfaces with a surface of the skin tissue; and a motor-driven oscillator, coupled with the tilting ultrasound transducer, and configured to oscillate about an oscillation-axis relative to a surface of the skin tissue such that at least one of: a position of the body interface implement; and a tilt direction of the body interface implement, oscillates about the oscillation-axis; and a measurement assembly, configured for measuring body shape parameters of the treated body part with said ultrasound device, the measurement assembly comprising: a green screen; a plurality of scale-markers, positioned at a predetermined respective distance from each other to form a one-dimensional or two-dimensional plane parallel to the green screen, wherein the one-dimensional or two-dimensional plane is shared by the treated body part; IL291793/ at least one imaging device, operational for capturing images of the treated body part and the scale-markers on a background of the green screen; and a processor, configured to receive the images from the imaging device and to process the images to measure body shape parameters of the treated body part.

2. The system of claim 1, wherein a propagation direction of the ultrasound energy is tilted respective of the surface of the skin tissue at a non- perpendicular angle.

3. The system of claim 1, wherein the oscillator is configured to oscillate the propagation direction of the ultrasound energy by dynamically changing a transmittal direction of the ultrasound waves relative to the body interface implement.

4. The system of claim 1, wherein a plurality of ultrasound transducers is positioned on the skin tissue, and wherein the oscillator is configured to oscillate the propagation direction of the ultrasound energy by activating and deactivating each of the ultrasound transducers respectively according to a sequence pattern.

5. The system of claim 1, wherein the body interface implement is configured to be tilted with respect to the surface of the skin tissue, forming a non- IL291793/ straight tilting transducer angle between an axis parallel to the body interface implement and an axis parallel to the skin surface, and wherein the oscillator is configured to oscillate so as to dynamically change the tilting transducer angle while massaging the skin tissue.

6. The system of claim 1, wherein the oscillator is moveable along a trajectory.

7. The system of claim 1, further comprising a distal engagement ring, encompassing the tilting ultrasound transducer and configured to be selectively extended in a distal direction to engage the skin tissue, so as to stabilize the ultrasound device when the tilting ultrasound transducer is activated.

8. The system of claim 1, wherein the ultrasound energy comprises a frequency in the range of 0.5-4.5 MHz.

9. The system of claim 1, wherein the ultrasound energy comprises an intensity in the range of 0.1-3.5 W/cm2.

10. The system of claim 1, wherein the body interface implement is configured to be tilted with respect to the surface of the skin tissue, forming a tilting transducer angle in the range of 0.5°-30° between an axis parallel to the IL291793/ body interface implement and an axis parallel to the surface of the skin tissue.

11. The system of claim 10, wherein the tilting transducer angle is 3.5°.

12. The system of claim 1, wherein a propagation direction of the ultrasound energy within the internal tissue forms at least one of: a divergent conic- like pattern; and a convergent conic-like pattern.

13. The system of claim 1, further comprising a plurality of electrodes configured to apply interferential electrical stimulation to the skin tissue during the operation of the tilting ultrasound transducer.

14. The system of claim 1, further comprising at least one suction unit configured to apply vacuum suction to the skin tissue during the operation of the tilting ultrasound transducer.

15. The system of claim 1, further comprising at least one stabilizing arm coupled with a main body of the device for stably positioning the ultrasound device at the skin tissue, allowing automatic maneuvering of the device to roam over the skin tissue.

16. The system of claim 1, further comprising at least one non-tilting ultrasound transducer, configured to be deployed onto the skin tissue and to transmit ultrasound energy onto the skin tissue. IL291793/

17. The system of claim 1, wherein the oscillation of a plurality of the tilting ultrasound transducers is coordinated to create an interference pattern in the internal tissue.

18. The system of claim 1, wherein a plurality of the tilting ultrasound transducers forms an integrated transducer unit configured to oscillate at the skin tissue, such that each transducer in the unit moves correspondingly with the oscillation of the unit.